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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP910023
Supplement NumberS056
Date Received09/17/2001
Decision Date10/15/2001
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for minor updates to the device software for the photon dr icd (model v-230hv) and the photon micro (u) vr/dr icds (models v-194/v-232) and minor updated to the programmer software supporting the model 3500 and model 3510 programmers as well as the software supporting the pr-1500 and pr-3500 model programmers.
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